Cardiolip tabs 5mg #30

Instruction for Cardiolip

Reed more and buy Cardiolip on this page

Cardiolip is a hypolipidemic agent.

Release form and composition

Dosage form - film-coated tablets: from light pink to pink, round, biconvex; the transverse section shows a pink shell and a core of almost white or white color (10 pcs. in blisters, in a cardboard box instructions for the use of Cardiolip and 3, 6 or 9 blisters).
Composition of 1 tablet:
    active substance: rosuvastatin calcium - 5.21 / 10.42 / 20.84 mg, which corresponds to the content of rosuvastatin - 5/10/20 mg;
    auxiliary components: magnesium stearate, pregelatinized starch, colloidal silicon dioxide (aerosil), microcrystalline cellulose;
    film shell: opadry II pink, including talc, titanium dioxide, polyvinyl alcohol, macrogol (polyethylene glycol) and carmine red dye (E120).

Pharmacodynamics

Rosuvastatin is a cholesterol precursor (CS), a selective competitive inhibitor of the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, which converts HMG-CoA to mevalonate. It acts primarily on the liver, where cholesterol is synthesized and low-density lipoprotein (LDL) catabolism occurs. Increases the number of LDL receptors on the surface of liver cells, increasing the uptake and breakdown of LDL. As a result, the synthesis of very low density lipoproteins (VLDL) is inhibited. As a consequence, the total amount of LDL and VLDL decreases.
Rosuvastatin lowers the concentration of triglycerides (TG), total cholesterol (TC), LDL cholesterol (LDL-C), TG-VLDL, VLDL cholesterol. Increases the level of high-density lipoprotein cholesterol (HDL-C) and the concentration of apolipoprotein A-I (Apo A-I).
Under the action of Cardiolip, the atherogenic index [(TC - HDL-C) / HDL-C] decreases, which improves the lipid profile in patients with hypercholesterolemia.
The clinical effect develops during the first week of treatment, reaches a maximum by the fourth week and persists with regular use of Cardiolip.
When using a lipid-lowering agent in combination with fenofibrate and nicotinic acid (in doses that reduce the concentration of lipids), an additive effect is noted. But the doctor determines the possibility of using such combinations on an individual basis after assessing the potential risks.

Pharmacokinetics

The main pharmacokinetic characteristics of rosuvastatin:
    absorption: Cmax (maximum plasma concentration) is achieved approximately 5 hours after oral administration of Cardiolip. The F (absolute bioavailability) value is about 20%;
    distribution: Vd (volume of distribution) ~ 134 l. Approximately 90% of the dose taken binds to plasma proteins, mainly albumin;
    metabolism: rosuvastatin undergoes limited metabolism (about 10%) mainly in the liver with the participation of the isoenzyme CYP2C9, to a lesser extent - CYP2D6, CYP2C19 and CYP3A4. The main metabolites found are inactive lactone metabolites and N-desmethylrosuvastatin, the activity of which is 50% of that of rosuvastatin. Inhibition of HMG-CoA reductase by 90% is carried out by rosuvastatin, by 10% by its metabolites;
    excretion: about 90% of the dose taken (unabsorbed and absorbed rosuvastatin) is excreted through the intestines unchanged, the rest is excreted by the kidneys. T1 / 2 (half-life) is 19 hours, with an increase in the dose of Cardiolip, this indicator remains unchanged. Plasma clearance - about 50 l / h;
    linearity: with daily administration, the pharmacokinetics of rosuvastatin does not change. Its systemic exposure increases in proportion to the dose.
Pharmacokinetics in special cases:
    renal function: in severe renal failure [creatinine clearance (CC) <30 ml / min], the plasma concentration of rosuvastatin increases 3 times, N-desmethylrosuvastatin - 9 times compared with healthy volunteers. In patients receiving hemodialysis, the concentration of the substance in the plasma increases by about 2 times;
    liver function: in patients with class B hepatic insufficiency according to the Child-Pugh classification, the T1 / 2 of rosuvastatin increases at least 2 times. There is no experience with its use in patients with class C liver failure.

Indications for use

Indications for use of Cardiolip:
    primary hypercholesterolemia: type IIa (including familial heterozygous hypercholesterolemia) and type IIb (mixed hypercholesterolemia) according to Fredrickson's classification - in addition to diet, if non-drug methods in combination with diet do not give the desired effect;
    hypertriglyceridemia IV type according to the Fredrickson classification - in addition to diet;
    familial homozygous hypercholesterolemia - in addition to other lipid-lowering therapy and diet, or if they are ineffective;
    primary prevention of major complications of the cardiovascular system (arterial revascularization, stroke, myocardial infarction) in the presence of a risk of coronary heart disease (IHD) in men over 50 and women over 60;
    primary prevention of major complications of the cardiovascular system in patients with an increased concentration (≥ 2 mg / L) of C-reactive protein and the presence of at least one additional risk factor (smoking, low HDL-C concentration, arterial hypertension, early onset of coronary artery disease in a family history ).
Cardiolip is also prescribed for patients who need therapy aimed at lowering the concentrations of TC and LDL-C in order to slow the progression of atherosclerosis.

Contraindications

Absolute:
    severe functional disorders of the kidneys (CC <30 ml / min);
    active liver disease, including a persistent increase in liver enzymes or an increase in transaminase activity ≥ 3 times compared with the upper limit of the norm at the start of treatment;
    myopathy, risk factors for the development of myotoxic complications;
    age under 18;
    lack of adequate methods of contraception in women of fertile age, pregnancy planning, pregnancy, lactation;
    concomitant use of cyclosporine;
    hypersensitivity to any component of Cardiolip tablets.
Additional contraindications for prescribing the drug in a daily dose of 40 mg:
    moderate renal failure (CC 30-60 ml / min);
    hypothyroidism;
    conditions in which an increase in the concentration of rosuvastatin in blood plasma is possible;
    personal or family history of muscle disease;
    excessive alcohol consumption;
    simultaneous use of fibrates;
    anamnestic data on the development of myotoxicity while receiving fibrates or other inhibitors of HMG-CoA reductase;
    belonging to the Mongoloid race.
Relative contraindications (Cardiolip should be used with caution):
    arterial hypotension;
    a history of liver disease;
    severe water and electrolyte, metabolic or endocrine disorders;
    sepsis;
    extensive surgical interventions and injuries;
    uncontrolled seizures;
    age over 65.
Additional relative contraindications for Cardiolip:
    daily dose of 5, 10 and 20 mg: excessive alcohol consumption, belonging to the Mongoloid race, conditions in which an increase in the level of rosuvastatin in the blood plasma is possible, the simultaneous use of fibrates, the presence of a risk of myopathy / rhabdomyolysis (hypothyroidism, renal failure, muscle diseases in the personal or family history, anamnestic data on the development of myotoxicity during therapy with fibrates or other inhibitors of HMG-CoA reductase;
    daily dose of 40 mg: renal failure (CC> 60 ml / min).

Cardiolip, instructions for use: method and dosage

Cardiolip is indicated for oral administration. The tablets must be swallowed whole with water. They cannot be crushed or chewed. Food intake does not affect the effectiveness of the drug.
Before starting lipid-lowering therapy, the patient should follow the generally accepted cholesterol-lowering diet prescribed by the doctor. It should be adhered to throughout the entire period of treatment.
The doctor determines the optimal daily dose of the drug individually, depending on the current lipid concentrations, cholesterol content, as well as the results to be achieved and the patient's therapeutic response to treatment. This takes into account the presence / absence of risks of developing cardiovascular complications.
It is recommended to start the course with a daily dose of 5 or 10 mg 1 time per day. If the therapeutic effect is insufficient, the dose may be increased after 4 weeks.
Patients receiving the maximum permissible daily dose of Cardiolip (40 mg) should be closely monitored. Such a high dose can only be prescribed to patients with severe hypercholesterolemia and a high risk of complications from the cardiovascular system, if there are no absolute contraindications, the desired result was not achieved with a dose of 20 mg, and it is possible to ensure the supervision of a specialist.
The use of Cardiolip in doses above 40 mg is not justified, since it is associated with an increase in the frequency of side effects and their severity.

Side effects

Adverse reactions identified in clinical studies of rosuvastatin:
    immune system: rarely - hypersensitivity reactions;
    digestive system: often - abdominal pain, nausea, constipation; rarely - pancreatitis;
    central nervous system: often - dizziness, headache;
    endocrine system: often - the development of type 2 diabetes mellitus;
    musculoskeletal system: often - myalgia; rarely - myopathy / rhabdomyolysis, including acute renal failure;
    urinary system: very rarely - proteinuria;
    dermatological reactions: infrequently - skin rashes, urticaria, itching;
    laboratory indicators: rarely - dose-dependent increase in the activity of liver enzymes, concentration of alkaline phosphatase, bilirubin and glucose, activity of gamma-glutamyl transpeptidase, thyroid dysfunction;
    others: often - asthenia.
Side effects of the drug, identified during post-marketing observations:
    hematopoietic system: unknown frequency - thrombocytopenia;
    digestive system: very rarely - jaundice, hepatitis; unspecified frequency - diarrhea;
    musculoskeletal system: very rarely - arthralgia; unspecified frequency - immune-mediated necrotizing myopathy;
    central nervous system: very rarely - decrease / loss of memory; unspecified frequency - peripheral neuropathy;
    respiratory system: unknown frequency - shortness of breath, cough;
    urinary system: very rarely - hematuria;
    skin and subcutaneous tissue: unknown frequency - Stevens-Johnson syndrome;
    others: unknown frequency - gynecomastia, peripheral edema.

Overdose

There are no specific symptoms of rosuvastatin overdose. In the case of taking an excessive dose of the drug, an increase in side effects is observed.
The specific antidote is unknown. It is recommended to flush the stomach as soon as possible. Further treatment is symptomatic. Control of hepatic function and creatine phosphokinase (CPK) activity is required. If necessary, measures are taken to maintain the functions of vital organs. Hemodialysis is ineffective.

Special instructions

When prescribing the drug, the doctor should warn patients that they should immediately come to the appointment if muscle pain, muscle weakness or muscle spasms suddenly appear, especially in cases where these conditions are accompanied by fever and malaise. In such patients, it is necessary to determine the activity of CPK. If this indicator exceeds the upper limit of the norm by 5 or more times, the drug is canceled. The course is also interrupted with pronounced muscle symptoms, especially causing daily discomfort, even if the CPK activity is not excessively increased. The decision to repeat therapy is considered after the disappearance of symptoms and the normalization of CPK activity.
After 2-4 weeks after the start of taking the drug, as well as after increasing its dose, it is necessary to monitor the indicators of lipid metabolism and, if necessary, adjust the dose of rosuvastatin.
It is recommended to check the indicators of the functional state of the liver before starting treatment and after three months. If the activity of liver enzymes exceeds the upper limit of the norm by 3 or more times, the drug is canceled or its dose is reduced.
In patients with hypercholesterolemia, developed against the background of nephrotic syndrome or hypothyroidism, prior to the appointment of rosuvastatin, therapy for the underlying diseases should be carried out.

Influence on the ability to drive vehicles and complex mechanisms

Due to the likelihood of dizziness and general weakness, during treatment with the drug, it is recommended to be careful when driving a car and performing work that requires attention and speed of reactions.

Application during pregnancy and lactation

Cardiolip is not used during pregnancy and lactation.
Women of reproductive age should use reliable contraceptive methods during therapy. If pregnancy is diagnosed during treatment with the drug, it should be canceled immediately.

Childhood use

Cardiolip is contraindicated in children under 18 years of age.

With impaired renal function

In daily doses of 5, 10 and 20 mg Cardiolip tablets are contraindicated in patients with severe functional impairment of the kidneys (CC <30 ml / min), in a daily dose of 40 mg - in patients with moderate renal dysfunction (CC 30-60 ml / min).
In addition, in a daily dose of 40 mg, the drug should be used with caution in patients with mild renal impairment (CC> 60 ml / min).

For violations of liver function

Cardiolip is contraindicated in patients with active liver disease.
Persons who abuse alcohol, the drug in daily doses of 5, 10 and 20 mg should be used with caution, in a daily dose of 40 mg is prohibited.

Use in the elderly

With caution, lipid-lowering therapy is carried out in patients aged 65 and over.

Drug interactions

Possible pharmacological interaction of the drug with substances / preparations used simultaneously:
    inhibitors of transport proteins: it is possible to increase the plasma concentration of rosuvastatin and increase the risk of myopathy;
    cyclosporine: significantly increases the AUC of rosuvastatin;
    inhibitors of HIV protease (human immunodeficiency virus): a significant increase in Cmax and AUC (area under the concentration-time curve) of rosuvastatin is possible, therefore such combinations are not recommended;
    gemfibrozil and other lipid-lowering agents: increase the Cmax and AUC of rosuvastatin;
    lipid-lowering doses of niacin (more than 1000 mg / day), fenofibrate, gemfibrozil and other fibrates: the risk of myopathy increases;
    ezetimibe: in patients with hypercholesterolemia, the AUC of rosuvastatin increases;
    antacids containing magnesium and aluminum hydroxide: the plasma concentration of rosuvastatin decreases almost 2 times, and therefore it is recommended to observe at least 2-hour intervals between their doses;
    erythromycin: decrease by 20% AUC and 30% Cmax of rosuvastatin;
    statins: the risk of developing rhabdomyolysis increases:
    vitamin K antagonists: possibly increased INR (International Normalized Ratio);
    oral contraceptives used for hormone replacement therapy: increases the AUC of norgestrel and ethinyl estradiol.
Correction of the dose of Cardiolip may be required with the simultaneous use of any of the following drugs: cyclosporine, atazanavir, ritonavir, simeprevir, lopinavir, clopidogrel, gemfibrozil, eltrombopag, darunavir, tipranavir, dronedarone, itraconazole, ezetimycinimib.

Terms and conditions of storage

Store in its original packaging out of the reach of children at temperatures up to 25 ° C.
Shelf life is 3 years.

Reviews about Cardiolip

According to reviews, Cardiolip is an effective lipid-lowering agent that lowers the level of "bad" cholesterol, prevents strokes and heart attacks, and prolongs life.
The lack of the drug includes multiple contraindications and a large list of possible side effects, including quite serious ones.

Terms of sell

You don't need a prescription to buy Cardiolip online.